Upon receipt, applications
will be evaluated for completeness by the Center for Scientific Review, NIH.
Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of
applications from Grants.gov and the Commons. The submitting AOR receives
the Grants.gov acknowledgments. The AOR and the PI receive Commons acknowledgments.
Information related to the assignment of an application to a Scientific Review
Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction (3 pages maximum) addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants Policy
Statement.
Pre-award costs are allowable.
A grantee may, at its own risk and without NIH prior approval, incur obligations
and expenditures to cover costs up to 90 days before the beginning date of
the initial budget period of a new or competing renewal (formerly competing
continuation ) award if such costs: are necessary to conduct the project,
and would be allowable under the grant, if awarded, without NIH prior approval.
If specific expenditures would otherwise require prior approval, the grantee
must obtain NIH approval before incurring the cost. NIH prior approval is
required for any costs to be incurred more than 90 days before the beginning
date of the initial budget period of a new or competing renewal award.
The incurrence of pre-award costs in anticipation
of a competing or non-competing award imposes no obligation on NIH either
to make the award or to increase the amount of the approved budget if an award
is made for less than the amount anticipated and is inadequate to cover the
pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award
costs result in borrowing against future support and that such borrowing must
not impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See the NIH Grants
Policy Statement.
6. Other Submission Requirements
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
PHS398 Research Plan Component Sections
Items 2-5 of the PHS398 Research Plan component are limited to 25 pages. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
Special Instructions for Modular Grant applications
R01 applications from U.S. institutions/organizations requesting up to $250,000 per year in direct costs (excluding consortium F&A costs) must be submitted in a modular budget format. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. When submitting a modular budget, the applicant organization will include only the PHS398 Modular Budget component. See Section 5.4 of the SF424 (R&R) Application Guide for further instructions regarding the use of the PHS398 Modular Budget component.
Foreign organizations may not submit modular budgets. See NOT-OD-06-096.
Special Instructions for Applications Requesting $500,000 (direct costs) or More Per Year
Applicants requesting $500,000
or more in direct costs for any year (excluding consortium F&A costs)
must carry out the following steps:
1) Contact the IC program staff at least 6 weeks before
submitting the application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC
staff that the IC will accept your application for consideration for award;
and,
3) Include the PHS398 Cover Letter component with
the application to identify the staff member and IC who agreed to accept assignment
of the application.
This policy applies to all new applications, competing renewal (formerly competing continuation ) applications, resubmission (formerly revised/amended ) applications, and revision (formerly competing supplemental ) applications. See NOT-OD-02-004, October 16, 2001.
Appendix Materials
IMPORTANT NOTE: NIH has published new limitations on grant
application appendix materials to encourage applications to be as concise
as possible while containing the information needed for expert scientific
review.
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Foreign Applications (Non-domestic (non-U.S.) Entity)
- Indicate how the proposed project has specific relevance to the mission and objectives of the IC and has the potential for significantly advancing the health sciences in the United States.
Plan for Sharing Research Data
The precise content of the
data-sharing plan will vary, depending on the data being collected and how
the investigator is planning to share the data. Applicants who are planning
to share data may wish to describe briefly the expected schedule for data
sharing, the format of the final dataset, the documentation to be provided,
whether or not any analytic tools also will be provided, whether or not a
data-sharing agreement will be required and, if so, a brief description of
such an agreement (including the criteria for deciding who can receive the
data and whether or not any conditions will be placed on their use), and the
mode of data sharing (e.g., under their own auspices by mailing a disk or
posting data on their institutional or personal Web site, through a data archive
or enclave). Investigators choosing to share under their own auspices may
wish to enter into a data-sharing agreement. References to data sharing may
also be appropriate in other sections of the application.
Applicants requesting more than $500,000 in direct
costs in any year of the proposed research must include a plan for sharing
research data in their application. The funding organization will be responsible
for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of the data sharing plan or the
rationale for not sharing research data may be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score.
Sharing Research Resources
NIH policy expects that grant
recipients make unique research resources readily available for research purposes
to qualified individuals within the scientific community after publication
(See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The effectiveness
of the resource sharing will be evaluated as part of the administrative review
of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
Reporting.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications submitted for this funding opportunity
will be assigned to the ICs on the basis of established PHS referral guidelines.
Appropriate scientific review groups convened in accordance
with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications will:
- Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
- Receive a written critique.
- Receive a second level of review by the appropriate national advisory council or board.
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
- Scientific merit of the proposed project as determined by peer review.
- Availability of funds.
- Relevance of program priorities.
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
- Significance
- Approach
- Innovation
- Investigator
- Environment
Note that an application does not need to be strong
in all categories to be judged likely to have major scientific impact and
thus deserve a high priority score. For example, an investigator may propose
to carry out important work that by its nature is not innovative but is essential
to move a field forward.
Significance:
Does this study address an important problem? If the aims of the application
are achieved, how will scientific knowledge, public health, or clinical practice
be advanced? What will be the effect of these studies on the concepts, methods,
technologies, treatments, services, or preventative interventions that drive
this field? Do the intervention efficacy data justify dissemination
and implementation? If the aims of the proposed project are achieved, how
will dissemination and implementation knowledge be advanced? What will be
the effect on the concepts or methods that drive this field? Will the
study have a clear positive impact on public health and community as well
as clinical contexts? How broad a reach (to the population that will benefit
from the knowledge/intervention) will be achieved by the dissemination and
implementation of the intervention through the knowledge/service delivery
contexts selected?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs? Are the administrative plans for the management of the research project appropriate, including plans for resolving conflicts? Has the applicant made appropriate changes in the intervention design based on the current state-of-the-art and or contextual factors relevant to dissemination and/or implementation? Does the applicant demonstrate an understanding of dissemination and implementation research principles? Is the dissemination or implementation approach appropriate to the problem and population? Are the procedures to assess the dissemination or implementation program appropriate? Is the evaluation plan linked to the dissemination or implementation plan and does the evaluation incorporate the best available data to track dissemination or implementation process and impact? How appropriate are the plans to sustain effective dissemination and implementation approaches once the research-funding period has ended?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms, public health, or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area? Does the proposed dissemination or implementation research contribute new and innovative design approaches to the study of dissemination or implementation process and/or outcomes?
Investigators: Are the PD/PIs and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Does the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)? Does the investigative team include specific dissemination and implementation expertise? Relevant letters of support from key partner dissemination and implementation organizations, which plan to adopt the intervention, are expected.
Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Do the proposed approaches take advantage of unique features of the intervention delivery environment or employ useful, collaborative arrangements? Is there evidence of institutional support to sustain dissemination or implementation interventions once the research funding ends?
2.A. Additional Review Criteria
In addition to the above criteria, the following items
will continue to be considered in the determination of scientific merit and
the priority score:
Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
Protection of Human Subjects from Research Risk:
The involvement of human subjects and protections from research risk relating
to their participation in the proposed research will be assessed. See the
Human Subjects Sections of the PHS398 Research Plan component of the SF424
(R&R).
Inclusion of Women, Minorities and Children in Research: The adequacy
of plans to include subjects from both genders, all racial and ethnic groups
(and subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See the Human Subjects Sections of the PHS398 Research
Plan component of the SF424 (R&R).
Care and Use of Vertebrate Animals in Research: If vertebrate animals
are to be used in the project, the adequacy of the plans for their care and
use will be assessed. See the Other Research Plan Sections of the PHS398
Research Plan component of the SF424 (R&R).
Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the proposed
protection is adequate.
2.B. Additional Review Considerations
Budget and Period of Support: The reasonableness of the proposed budget
and the appropriateness of the requested period of support in relation to
the proposed research may be assessed by the reviewers. The priority score
should not be affected by the evaluation of the budget.
Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the data sharing plan or the rationale
for not sharing research data may be assessed by the reviewers. However, reviewers
will not factor the proposed data sharing plan into the determination of scientific
merit or the priority score. The funding organization will be responsible
for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.
2.D. Sharing Research Resources
NIH policy expects that grant recipients make unique
research resources readily available for research purposes to qualified individuals
within the scientific community after publication (See the NIH Grants Policy
Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the administrative
review of the plan for sharing research resources.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., Reporting.
Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations.
3. Anticipated Announcement and
Award Dates
Not Applicable
Section VI. Award Administration
Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able
to access his or her Summary Statement (written critique) via the NIH eRA
Commons.
If the application is under
consideration for funding, NIH will request "just-in-time" information
from the applicant. For details, applicants may refer to the NIH Grants
Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart
A: General.
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via
email notification from the awarding component to the grantee business official.
Selection of an application for award is not an authorization
to begin performance. Any costs incurred before receipt of the NoA are at
the recipient's risk. These costs may be reimbursed only to the extent considered
allowable pre-award costs. See Section IV.5., Funding Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA. For these terms
of award, see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General and Part II:
Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
3. Reporting
When multiple years are involved, awardees will be
required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required
in the NIH
Grants Policy Statement.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
David A. Chambers, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
Neuroscience Center, Room 7133 MSC 9631
Bethesda, MD 20892-9631
Telephone: (301) 443-3747
FAX: (301) 443-4045
Email: [email protected]
Chris Gordon, Ph.D.
Division of AIDS and Health and Behavior Research
National Institute of Mental Health
Neuroscience Center, Room 6199 MSC 9619
Bethesda, MD 20892-9619
Telephone: (301) 443-1613
FAX: (301) 443-9719
Email: [email protected]
Jon F. Kerner, Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd., EPN 6144
Bethesda, MD 20892-7338
Telephone: (301) 594-7294
FAX: (301) 443-4505
Email: [email protected]
Redonna K. Chandler, Ph.D.
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Blvd.
Room 5177, MSC 9589
Bethesda, MD 20892-9589
Rockville, MD 20852 (for express/courier service)
Phone: (301) 443-6504
Fax: (301) 443-6815
E-mail: [email protected]
Amy Donahue, Ph.D.
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400C-10
Bethesda, MD 20892-7180
Telephone: (301) 402-3458
Fax: (301) 402-6251
Email: [email protected]
Susan D. Solomon, Ph.D.
Senior Advisor
Office of Behavioral and Social Sciences Research
National Institutes of Health, Office of the Director
Building One, Room 256, NIH
One Center Drive
Bethesda, MD 20892-0183
Telephone: (301) 496-0979
Fax: (301) 402-1150
E-mail: [email protected]
Karen Huss, PhD, RN, APRN-BC, FAAN, FAAAAI
Program Director, Cardiopulmonary & Critical Care Science, Training Coordinator
National Institute of Nursing Research
6701 Democracy Blvd., Rm 710
One Democracy Plaza
Bethesda, MD 20892-4870
Phone: 301-594-5970
Fax: 301-451-5649
Email: [email protected]
Peter J. Delany, Ph.D.
Program Director for Health Services Research
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
5635 Fishers Lane, Rm 2039
Bethesda, MD 20892-9304
Telephone: (301) 443-0788
Fax: (301) 443-8774
Email: [email protected]
Ruth Nowjack-Raymer, MPH, PhD
Director, Health Disparities Research Program
Center for Clinical Research
National Institute of Dental and Craniofacial Research
Building 45, Room 4AS-43F
Bethesda, Maryland 20892-6401
Telephone: (301) 594-5394
FAX: (301) 480-8322
Email: [email protected]
Lawrence J. Fine M.D., Dr.P.H.
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
6701 Rockledge Dr. , Room 8138, MSC7936
Bethesda MD 20892-7936
Telephone: (301) 435-0305
Fax: (301) 480-1669
Email: [email protected]
Elizabeth A. Yetley, Ph.D.
Senior Nutrition Research Scientist
Office of Dietary Supplements
National Institutes of Health
6100 Executive Boulevard, Suite 3B01
Bethesda MD 20892-7517
Telephone: (301) 496-0217
Fax: (301) 480-1845
Email: [email protected]
2. Peer Review Contact(s):
Steven H. Krosnick, M.D.
SRA, Health of the Population (HOP) Integrated Review Group
Center for Scientific Review (CSR), NIH
6701 Rockledge Drive, Room 3028A, MSC 7770
Bethesda, MD 20892-7770 (20817 for overnight mail)
Telephone: (301) 435-1712
Fax: (301) 480-1056
Email: [email protected]
3. Financial/Grants Management Contact(s):
Joy R. Knipple
Grants Management Branch
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6131 MSC 9605
Bethesda, MD 20892-9605
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-8811
FAX: (301) 443-6885
Email: [email protected]
Crystal Wolfrey
Grants Management Branch
Division of Extramural Activities
National Cancer Institute
6120 Executive Blvd, EPS 243
Bethesda, MD, 20892-7150
Telephone: (301) 496-8634
FAX: (301) 496-8601
Email: [email protected]
Pamela Fleming
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Suite 270
Bethesda, MD 20892-8403
Phone: (301) 435-1369
Fax: (301) 594-6849
E-mail: [email protected]
Christopher Myers
National Institute on Deafness and Other Communication Disorders
Grants Management Branch
6120 Executive Blvd., EPS Room 400B
Bethesda, MD 20892-7180
Phone: (301) 435-0713
Fax: (301) 402-1758
Email: [email protected]
Brian Albertini
Chief, Office of Grants and Contracts Management
National Institute of Nursing Research
National Institutes of Health
6701 Democracy Blvd, Room 710
One Democracy Plaza
Bethesda, MD 20892-4870 (Courier use 20817)
Telephone: (301) 594-6869
Fax: (301) 402-4502
Email: [email protected]
Judy S. Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3021
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
FAX: (301) 443-3891
Email: [email protected]
Mary E. Daley
National Institute of Dental and Craniofacial Research
45 Center Drive, MSC 6402
Bethesda, MD 20892-6402
Phone: (301) 594-4800
Fax: (301) 480-8303
E-mail: [email protected]
Teresa Farris Marquette
Section Chief
Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7152, MSC 7926
Bethesda, MD 20892-7926
Telephone: (301) 435-0172
Fax: (301) 480-3310
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use
of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications
and proposals involving human subjects must be evaluated with reference to
the risks to the subjects, the adequacy of protection against these risks,
the potential benefits of the research to the subjects and others, and the
importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The establishment
of data and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risks to the participants
( NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and
Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include
a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions,
on issues related to institutional policies and local IRB rules, as well as
local, State and Federal laws and regulations, including the Privacy Rule.
Reviewers will consider the data sharing plan but will not factor the plan
into the determination of the scientific merit or the priority score.
Access to Research Data through
the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity
in a public archive, which can provide protections for the data and manage
the distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design and
include information about this in the budget justification section of the
application. In addition, applicants should think about how to structure informed
consent statements and other human subjects procedures given the potential
for wider use of data collected under this award.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model organisms
for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors
to elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH
Grants Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include
in the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to
a cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members
of minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators
proposing clinical research should read the "NIH Guidelines for Inclusion
of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new
OMB standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles
and responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description
of plans to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
Research:
The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all clinical research, conducted
or supported by the NIH, unless there are scientific and ethical reasons not
to include them.
All investigators proposing research involving human
subjects should read the "NIH Policy and Guidelines" on the inclusion
of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject
Participants:
NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key personnel.
The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs
can be found at http://stemcells.nih.gov/index.asp
and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole
or in part with direct costs from NIH. The author's final manuscript is defined
as the final version accepted for journal publication, and includes all modifications
from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in
whole or in part with direct costs from NIH, but it does not apply to book
chapters, editorials, reviews, or conference proceedings. Publications resulting
from non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission
process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov//
and view the Policy or other Resources and Tools, including the Authors' Manual.
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (HHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and enforced
by the HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and
a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and research
contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2010," a PHS-led national activity for setting priority areas. This PA
is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements
of Executive Order 12372 or Health Systems Agency review. Awards are made
under the authorization of Sections 301 and 405 of the Public Health Service
Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part
52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants Policy
Statement.
The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the
PHS mission to protect and advance the physical and mental health of the American
people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment
from qualified health professionals who have made a commitment to pursue a
research career involving clinical, pediatric, contraception, infertility,
and health disparities related areas. The LRP is an important component of
NIH's efforts to recruit and retain the next generation of researchers by
providing the means for developing a research career unfettered by the burden
of student loan debt. Note that an NIH grant is not required for eligibility
and concurrent career award and LRP applications are encouraged. The periods
of career award and LRP award may overlap providing the LRP recipient with
the required commitment of time and effort, as LRP awardees must commit at
least 50% of their time (at least 20 hours per week based on a 40 hour week)
for two years to the research. For further information, please see: http://www.lrp.nih.gov/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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